The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Impedance/8200 Monitor-model 8300.
| Device ID | K840358 |
| 510k Number | K840358 |
| Device Name: | IMPEDANCE/8200 MONITOR-MODEL 8300 |
| Classification | Tester, Electrode, Surface, Electrocardiographic |
| Applicant | AEQUITRON MEDICAL, INC. 14130 23RD. AVE. NORTH Minneapolis , MN 55441 - |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec AEQUITRON MEDICAL, INC. 14130 23RD. AVE. NORTH Minneapolis , MN 55441 - |
| Product Code | KRC |
| CFR Regulation Number | 870.2370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-26 |
| Decision Date | 1984-10-30 |